The Fair Pricing Coalition (FPC) commends the House Committee on Oversight and Government Reform for its hearing today on drug price increases for older, off-patent medications. The hearing was spurred by a 5,000% rise in the price of pyrimethamine (Daraprim) for toxoplasmosis. At the end of December 2015, the FPC urged Turing Pharmaceuticals to restore its lower price (already a hefty $13.50 a pill), and has been disappointed that no action has yet been taken. We hope the hearing leads to policy actions that prevent companies from having free rein to price-gouge older drugs with little or no competition.

On the heels of today’s hearing and other federal investigations into unjustified drug pricing, the FPC is outraged that manufacturers of some of the most frequently prescribed antiretrovirals for treatment of HIV ushered in exorbitant Wholesale Acquisition Cost (WAC) price increases with the new year. The WAC increases show complete disregard for a year-end plea by FPC to industry leaders urging them to refrain from any price increases or, barring that, certainly no increases over the medical Consumer Price Index (CPI).

“With committees in both houses of Congress investigating out-of-control drug pricing in response to intensifying public frustration, it defies logic that we’re starting 2016 with arbitrary increases in drug prices already at the upper limit of any conceivable justification,” said FPC Co-Chair Lynda Dee. “This trend is unsustainable and will continue to hinder patient access to life-saving HIV treatment and prevention, as well as curative hepatitis C regimens.”

“We made this point very clearly to executives at the major pharmaceutical companies in our annual plea for price freezes,” said FPC Co-Chair Murray Penner. “Yet our December 2015 letters went unheeded. We are once again looking at WAC increases mostly in the 7 to 8 percent range, all over last year’s exorbitant prices.”

Though the January 2016 CPIs—measures of inflation—have not yet been announced, the 2016 WAC increases for leading antiretrovirals are approximately three times higher than the ten-year CPI average of 2.5 percent. They are also higher than all medical CPI categories, which average 2 to 3 percent and are driven in part by unrestrained drug pricing (see preceding table).

Current drug prices are unsustainable and are preventing people living with HIV from accessing life-saving antiretrovirals. “HIV care providers are reporting an uptick in Medicaid and private plans requiring prior authorization for antiretroviral drugs, particularly for preferred standard-of-care single tablet regimens,” said FPC member Andrea Weddle. “Most concerning are provider reports that some insurance coverage requests are being denied outright. While denials are presently rare, it is nonetheless disturbing that people living with HIV are now facing these sorts of challenges.”

Egregious drug pricing has also resulted in a clear inability of people living with hepatitis C virus (HCV) to access many of the direct-acting antivirals (DAAs) that achieve as much as a 99% cure rate with minimal side effects. “Numerous health plans, both public and private, have instituted treatment utilization polices and prior authorization processes that are based on cost-containment concerns, rather than on the best and most current clinical science,” explained FPC member Emalie Huriaux. “Nowhere is this more apparent than in state Medicaid programs, many of which cover DAAs only for patients with advanced fibrosis or cirrhosis, contrary to published guidelines. Many of these programs also have policies that deny curative therapy to people who use drugs or alcohol, despite guidelines and clinical evidence that this population should be prioritized for treatment, both for their personal health and to prevent ongoing transmission of the virus.”

As exemplified by today’s House Committee on Oversight & Government Reform hearing, runaway drug pricing continues to be of tremendous interest to Congressmen, Senators, and presidential candidates of both parties. “The political pressure is now on, meaning there is yet another pragmatic reason for HIV and hepatitis C drug manufacturers to curb their overreach,” said FPC member Tim Horn. “In this election year, our hope is that industry will show restraint, and respect public awareness of the burgeoning crisis of health care financing. Unfortunately, it appears we’re not off to a very good start.”

The Fair Pricing Coalition (FPC) today expressed appreciation for Merck’s & Co. Inc.’s decision to launch its new curative hepatitis C (HCV) treatment, Zepatier, at a price below existing HCV treatments in a tacit acknowledgement that existing high prices have hurt patients and are untenable for the market. Zepatier’s $54,600 list price is lower than the egregious prices for Gilead Sciences’ Harvoni ($94,500) and AbbVie’s Viekira Pak ($83,319), and represents a step in the right direction. Even at this price, however, the FPC is still concerned that patients may not be able to afford to cure their HCV – preventing the U.S. from ending the HCV epidemic and increasing system-wide healthcare costs.

Merck’s lower price follows substantial public and Congressional scrutiny of HCV treatments. After an exhaustive investigation, the Wyden-Grassley Senate Finance Committee report concluded that Gilead Sciences’ HCV pricing was focused on “maximizing revenue,” not “fostering broad, affordable access.” While Merck’s lower price may increase patient access to HCV treatments, we hope that Merck will work to ensure that prior approval restrictions instituted by public and private payers will be eliminated once and for all.

“High costs of treatment have led insurers to severely restrict patient access to curative HCV treatment,” said FPC Co-Chair Lynda Dee. “While companies insist that patients will not bear the full cost of treatment, many patients are not receiving any treatment at all because insurers refuse to pay these exorbitant prices. Merck’s willingness to set Zepatier’s initial price lower than the competition must be followed with negotiated insurer discounts that allow patients easy access with minimal cost-sharing.”

As the population with HCV ages, public programs like Medicare are facing unprecedented costs from curative treatments. “Because Medicare is not allowed to negotiate for lower drug prices, Medicare spending exists at the whim of drug manufacturers,” explained FPC member Emalie Huriaux. “These costs are passed on, in part, to patients, who must pay a percentage of the drug’s cost as co-insurance. Merck’s lower price may reduce some Medicare costs, but patients will still face massive cost-sharing, hurting their ability to access necessary treatment.” We hope Merck will offer Medicare and Medicaid programs additional rebates so that very needy patients will be able to access this exciting new HCV regimen.

Excessive HCV prices have led insurers to routinely deny patient access to lifesaving HCV treatment, including refusing treatment to patients without advanced fibrosis or those who have recent histories of substance use. These practices have no medical basis. The FPC commends Merck for studying the efficacy of Zepatier in patients who use drugs. For any denials by insurers, HCV drug manufacturers must ensure broad patient assistance programs are available to fill in the gaps, guaranteeing that patients receive necessary treatment.

“Recently, Gilead Sciences changed its patient assistance program to refuse free treatment to individuals denied access by their insurer,” said FPC member Tim Horn. “We hope that Merck’s lower pricing means they will reject this deplorable practice and provide free access to patients denied by public and private payers.”

“We will be watching closely to ensure that Merck has robust patient assistance and co-pay assistance programs,” added FPC co-chair Murray Penner. “Merck must ensure that all patients, including Medicaid patients, often the most financially needy of all, have access to Zepatier.”

“The report, which took 18 months to complete, is amazingly thorough and comprehensive, worthy of the US Senate and a Pulitzer Prize for investigative reporting,” said FPC co-chair Lynda Dee.

Sovaldi was approved by the FDA on December 6, 2013—a first-in-class hepatitis C drug that helped usher in a new era of short-course, all-oral, well-tolerated, and highly curative treatment.

Unfortunately, Gilead turned this long-awaited treatment option into a perfect storm of near-impossible drug access, marked by public and private insurance roadblocks in the form of prior approval, fibrosis, and strict sobriety requirements. These were instituted because government and industry payers could not afford the unconscionable cost of Sovaldi (a wholesale acquisition cost of $1,000 per pill for a total of $84,000 for a typical course of hepatitis C treatment) and later Harvoni ($94,500 for a typical treatment course).

Dee, cured of hepatitis C using a Sovaldi-inclusive regimen, explained: “With tears in my eyes, I literally begged Gilead at their FDA approval hearing to price Sovaldi reasonably so that it could be accessed by the hundreds of thousands of people who had been waiting so long for effective, less toxic hepatitis C treatments. The FPC met with Gilead before the launches of both Sovaldi and Harvoni, urging them to set their prices reasonably to avoid the cost-containment firestorm that is now the new normal for hepatitis C drugs. What was a dream scenario is currently a nightmare of bureaucratic insurance barriers.”

The Senate investigation found that Gilead provided supplemental rebates to only five Medicaid programs in 2014. “The poorest people in most of the country face the greatest access barriers to all the new hepatitis C regimens,” said FPC Co-Chair Murray Penner. “These barriers have worsened as Gilead recently narrowed eligibility for its Support Path program to exclude patients who have any form of insurance, even if that insurance denies access to Sovaldi and Harvoni. These barriers all result from unsustainable drug prices initiated by Gilead.”

The Senate report also provides clear evidence of Gilead’s greed and blatant disregard of stakeholder insight, stating: “Based on all of the information reviewed, it appears that in pricing its line of [hepatitis C] drugs Gilead may have underestimated the warnings of patient groups, insurers, health care providers, and other organizations about the potential impact that price would have on access…While publicly saying it prioritized patient access, Gilead set Sovaldi’s price at a level where ultimately many patients would not receive treatment. Sovaldi was on the market for almost a year without serious competitors, allowing Gilead to maintain a high effective price despite efforts by many payers to negotiate volume or treatment discounts or rebates.”

Additionally, according to the Wyden-Grassley report:

More than $1.3 billion was spent by Medicaid programs for Sovaldi in 2014, but only 2.4% of Medicaid patients with hepatitis C were actually treated because of the excessive price of Sovaldi.

In the 18 months that Gilead’s drugs have been on the market, Medicare’s monthly spending on hepatitis C treatments increased more than six-fold from $116.4 million in January 2014 to $793.2 million in June 2015.

Medicare’s average pre-rebate monthly spending on hepatitis C drugs grew to $765 million during the first six months of 2015, more than double the average monthly expenditure of $349.5 million.

Prisoners in the US Bureau of Prisons (BOP) system were also adversely affected. In fiscal year 2014, the year Sovaldi became available to treat prisoners with hepatitis C, the BOP’s spending on hepatitis C drugs increased 14%, even though the number of patients treated decreased 52%.

“This remarkable investigative report is an indictment against Gilead and the US drug pricing system which allows lifesaving drugs to be priced beyond what the market can reasonably bear,” said Dee.

At his press conference, Senator Wyden observed that drugs for other diseases like Alzheimer’s, diabetes, and cancer are in the pipeline. He noted that prices similar to those for the newest hepatitis C drugs are clearly not sustainable by private insurance companies and government payers.

The FPC wishes to thank Senators Wyden and Grassley, the Minority Staff of the Senate Finance Committee, and Senator Grassley’s staff for their Herculean efforts in compiling this investigative bipartisan report on hepatitis C drug pricing based on over 20,000 documents. The FPC was delighted to assist in this investigation

The Fair Pricing Coalition, founded by the late Martin Delaney of Project Inform, is a national coalition of activists who work on HIV and viral hepatitis drug pricing issues and to help control drug costs for patients who are privately insured, underinsured and uninsured. The FPC also works to ensure access for recipients of state ADAPs, Medicare, and Medicaid as well as for other underinsured and uninsured individuals. For more information about the Fair Pricing Coalition and its history, visit: fairpricingcoalition.org.

The Fair Pricing Coalition (FPC) today welcomed Gilead Sciences’ pricing of its new single-tablet regimen Genvoya in parity with its predecessor Stribild. Though the wholesale acquisition cost (WAC) of $31,362 per year hardly reverses a trend of exorbitant drug pricing in the United States, it underscores a growing recognition that HIV treatment expenditures are beyond what the market can reasonably bear.

“Genvoya, the first coformulation to be approved containing tenofovir alafenamide (TAF), is an important improvement over Stribild containing tenofovir disoproxil (TDF), particularly for an aging population of people living with HIV at increased risk of kidney problems and bone density loss,” says Lynda Dee, co-chair of the Fair Pricing Coalition. “Our request to Gilead that Genvoya be priced neutrally with Stribild was heard. We now need to ensure that this welcome addition is priced affordably for all cash-strapped public insurance programs and that future TAF-inclusive coformulations are priced to ensure access for all people living with HIV.”

Genvoya’s WAC is the price point where many negotiations with payers begin and strident advocacy to further control costs continues. “The next step is for negotiations to proceed with public insurance programs that receive discounts and rebates that serve to lower the cost below the WAC price,” says FPC member David Evans. “Most of these programs are in fragile financial shape and, when considering TAF-inclusive regimens, will require parity with the deeply discounted prices of the older coformulations containing TDF. We appreciate Gilead’s stated commitment to negotiate in good faith with these programs and will be watching to make sure that takes place.”

FPC also implores Gilead to approach its WAC determinations for future TAF-inclusive coformulations, including FTC/TAF (F/TAF) and rilpivirine/FTC/TAF (R/F/TAF)—the company’s follow-up products to Truvada and Complera that are likely to be approved by the FDA in April and July, respectively—with caution. Whereas Genvoya contains 10 mg of TAF, R/F/TAF will contain 25 mg TAF and F/TAF will be available as two coformulations: one containing 10 mg TAF for use in regimens containing boosting agents and another containing 25 mg TAF for use in combination with antiretrovirals that don’t require boosting, such as dolutegravir.

“Our request to Gilead was that the highest dose of TAF to be used in combination with other antiretrovirals be priced in parity with TDF,” says Murray Penner, FPC co-chair. “A WAC price for either dosing formulation of F/TAF or rilpivirine/F/TAF that is above that for Truvada or Complera, two combination tablets that debuted at high prices and have undergone numerous cost hikes, would be a serious misstep.”

TAF-inclusive coformulations are entering the U.S. marketplace on the brink of a watershed moment in HIV drug pricing history. “An initial report of TAF’s potential advantages over TDF was published in 2001; it is a shame people living with HIV had to wait until 2015, just two years before TDF’s patent expiration, to take advantage of its more favorable kidney and bone toxicity profile,” said Tim Horn, an FPC member. “TAF’s net benefit over TDF, notably whether it will significantly reduce the risk of serious renal disease and bone fractures, is not totally clear. Additionally, the pending arrival of lower-cost generic TDF and generic-inclusive coformulations—along with the potential for regimens employing fewer drugs to achieve and maintain viral suppression—are important factors with which Gilead must contend.”

“Like Triumeq, ViiV’s single-tablet regimen approved in 2014 that is priced below the sum of its parts, the neutral pricing between Gilead’s Genvoya and Stribild hopefully signals an end to drug pricing that has spiraled out of control,” says FPC member Paul Arons, MD. “It’s now time for a downward trend, not only because of shifting dynamics in the marketplace, but because personal and public health benefits to people living with HIV require ready access to safe and effective treatment options, despite limited resources.”

In advance of the Fair Pricing Coalition’s October 12, 2015, meeting with Gilead Sciences’ senior staff to discuss wholesale acquisition costs (WACs) and access plans for tenofovir alafenamide fumarate (TAF)-inclusive coformulations, the signers of this letter urge your company to carefully consider product pricing that effectively addresses the need for cost-contained HIV care delivery in the United States.

As we are certain you are aware, payers have become increasingly conscious of price when making decisions about prescription drug coverage, even for life-threatening conditions such as HIV infection. This is evident in continued reliance on specialty drug tiering and the growing use of prior authorization by employer-based and Affordable Care Act health insurance plans. We are also seeing restricted access by state Medicaid programs and Medicaid managed care organizations, notably the downgrading of coformulated antiretrovirals to non-preferred status, subject to prior authorization and quantity limits.

People living with HIV and their healthcare providers welcome the anticipated benefits of substituting TAF for tenofovir disoproxil fumarate (TDF) as a component of elvitegravir/cobicistat/emtricitabine (E/C/F/TAF), rilpivirine/emtricitabine/TAF, and in 10 and 25 mg dosages coformulated with emtricitabine (F/TAF). We would like to ensure that all people living with HIV have access to these new formulations that may lower the risk of bone and kidney toxicity in accordance with phase III clinical trials (1). Access to TAF, however, may well hinge on the actual price paid by private health insurers, Medicaid programs, and AIDS Drug Assistance Programs (ADAPs).

We urge Gilead to price these new TAF-inclusive coformulations in parity with regimens containing TDF. This is particularly vital for Medicaid programs and ADAPs, where CPI penalties and discounts that Gilead has offered for TDF-inclusive coformulations have dramatically increased access through lower prices. Unless equivalent discounts are offered for TAF-inclusive coformulations, these drugs will be inaccessible to people living with HIV who need it most.

We are recommending that, with discounts and rebates, Gilead ensure that all payers do not pay more for TAF-inclusive regimens than TDF-inclusive regimens. Specifically, we urge that there be price parity based upon the 25 mg dose of TAF. The 10 mg dose in E/C/F/TAF and the second F/TAF coformulation should be priced proportionately lower.

The Fair Pricing Coalition (FPC) today expressed its dismay and frustration at manufacturers of some of the most frequently prescribed antiretrovirals for treatment of HIV, citing exorbitant Wholesale Acquisition Cost (WAC) price increases ushered in with the new year. The WAC price increases implemented by these industry leaders show complete disregard for an annual FPC year-end appeal calling for a two-year price freeze, with several companies setting 2015 prices that far exceed the typical rise in the Consumer Price Index (CPI).

“The FPC firmly believes that upwardly spiraling drug prices are already at the upper limit of any conceivable justification, are unsustainable, and will continue to hinder patient access to life-saving HIV treatment and prevention options, as well as recently approved curative hepatitis C virus (HCV) regimens,” said FPC Co-Chair Lynda Dee. “We made this point, plainly and clearly, to executives at the major pharmaceutical companies again in 2014, yet we are once more looking at WAC increases that are generally between 7 and 10 percent over last year’s already indefensible prices.”

Though the January 2015 CPIs—measures of inflation—have not yet been announced, the 2015 WAC price increases for leading antiretrovirals are two to three times higher than the ten-year CPI average of 2.5 percent; they are also higher than all medical CPI categories, which average 2 to 3 percent and are driven in part by unrestrained drug pricing.

“Several companies are, once again, guilty of unsubstantiated price gouging, with Bristol-Myers Squibb (BMS) being the most egregious example,” said FPC Co-Chair Murray Penner. “Despite that BMS was recently granted a reprieve on the anticipated 2014 loss of patent exclusivity for Sustiva, allowing it to reap an additional two years of exclusivity on U.S. sales of the drug, the company decided that this windfall occasioned by endless patent evergreening was not enough, and increased the 2015 WAC for Sustiva by nearly 10 percent—the largest price increase reported thus far this year. And this followed two 2014 increases, totaling 16.7 percent, contributing to a total price increase of approximately 150% since the drug was approved in 1998.”

Starting January 1, the annual WAC price for Sustiva (efavirenz) increased from $9,352 to $10,260. Importantly, this price increase directly impacts the WAC of the efavirenz-containing single-tablet regimen Atripla, which is now $25,874 per year, compared with $24,965 at the end of 2014. The 2015 Atripla annual WAC is also more than 85% higher than its 2006 launch price of approximately $13,800 per year.

Other notable WAC price increases reported on January 1 include Janssen Therapeutics’ Prezista (darunavir), Intelence (etravirine), and Edurant (rilpivirine) (7.9% each); a 6.9% increase in the WAC price for Merck’s Isentress (raltegravir), and a 7.9% increase in the WAC price for BMS’s Reyataz (atazanavir). WAC price increases for ViiV Healthcare’s HIV drug products are anticipated during the first quarter of 2015. AbbVie is not expected to increase the price on its drug products, at least not this quarter.
Shielded by claims of legal proscriptions, the companies notify FPC and the general public of price increases only after they have already been decided. As there is rarely an opportunity for comment or other public input into these price determinations, the FPC submitted letters to all of the major HIV drug manufacturers in December 2014, demanding a price freeze or, if absolutely necessary, no more than one price increase annually (some antiretroviral prices have been raised twice in one year), not to exceed the overall increase in the medical CPI for the preceding year. Letters also reiterated the need for more robust company patient savings programs to offset skyrocketing out-of-pocket (OOP) costs associated with these expensive medications being placed in specialty drug tiers.

“We commend many companies for complying with our requests for more generous assistance programs to help cushion the blow associated with exorbitant OOP costs, but we have been unambiguous in noting that ever-increasing drug prices only encourage payers to place all HIV and HCV medications in specialty tiers, and raise cost sharing requirements, and establish even more draconian prior authorization restrictions,” explained Dee. “Our demands that major HIV companies refrain from compounding the average consumer’s economic hardship and inflating prices beyond the brink of what health care delivery under the Affordable Care Act can reasonably bear have been ignored. The time has come to inform and mobilize the public regarding the pharmaceutical industry’s reluctance to heed reasonable requests regarding its unjustified pricing policies.”

The Fair Pricing Coalition (FPC) today condemned Gilead Sciences for the price set for its direct acting antiviral (DAA) Sovaldi™ (sofosbuvir), a once-daily, first-in-class nucleotide polymerase inhibitor approved by the U.S. Food and Drug Administration on December 6, 2013, for the treatment of chronic hepatitis C, including those co-infected with HIV. While FPC believes that all hepatitis C virus (HCV) drugs are priced too high, the coalition of HIV and viral hepatitis treatment activists is especially dismayed by the wholesale acquisition cost (WAC) of $84,000 for a 12-week course of Sovaldi™. For comparison purposes, the FPC notes the 12-week WAC for the recently approved NS3/4A protease inhibitor Olysio™ (simeprevir) is $66,360.

“Sovaldi™ is a very safe and highly effective drug that will significantly shorten HCV therapy and either reduce or eliminate the need for injected pegylated interferon,” explained FPC Co-Chair Lynda Dee. “However, this does not give Gilead unconscionable pricing carte blanche, particularly when considering that Sovaldi™ still needs to be combined with ribavirin for the treatment of HCV genotype 2 for 12 weeks or genotype 3 for 24 weeks. Twelve weeks of therapy with Sovaldi™ plus both pegylated interferon and ribavirin is required for the treatment of HCV genotype 1, the most common genotype in the US, and HCV genotype 4.”

The WAC for 12 weeks of HCV treatment with pegylated interferon and ribavirin is approximately $9,000, resulting in a combined WAC of $93,000 for a Sovaldi™-inclusive regimen to effectively treat a single person living with HCV genotypes 1 or 4. To treat HCV genotype 3, 24 weeks of Sovaldi™ plus ribavirin is required, resulting in a Sovaldi™ WAC of $168,000.

Price Portends an Ominous Future

“Gilead has set the bar dangerously high as other companies determine prices for similar hepatitis C drugs as they enter the market,” Dee said. The effectiveness of Sovaldi™ as a component of future pegylated interferon-free regimens for the treatment of HCV will ultimately depend on co-administration with other DAAs currently in development, and are anticipated to come with their own high price tags.

“Sovaldi™ is expected to transform the curative landscape for hundreds of thousands of people living with hepatitis C in the U.S. who require therapy or responded poorly to previous treatment,” said Lorren Sandt, FPC Co-Chair. “Yet the high price will result in significant barriers to treatment access, particularly in limited and fixed-budget programs, such as Medicare and state Medicaid programs, AIDS Drug Assistance Programs, the Veterans Administration, and in correctional systems.”

The high price may also lead to access challenges imposed by private insurance plans and Qualified Health Plans in the new Affordable Care Act (ACA) Marketplaces, notably those with high co-payment and other out-of-pocket requirements.

“There may be reluctance to add Sovaldi™ to formularies quickly and payers may force people living with HCV to engage in step therapy in which they are first required to try less expensive options that are less effective,” Sandt added. “These options take longer to complete and are associated with serious side effects, which present a serious impediment to adherence and, ultimately, to being cured of hepatitis C.”

Concessions Where They Count

Although Gilead refused FPC’s demand for fair pricing of Sovaldi™, the company has agreed to all FPC requests for concessions regarding Sovaldi™ access programs. These include:

The SupportPath™ (www.mysupportpath.com) patient assistance program (PAP), with a $100,000 maximum income allowance for a household of three and 500% of the federal poverty level (FPL) eligibility criteria for larger households.

The SupportPath™ Sovaldi™ co-pay coupon program will provide co-pay assistance for eligible patients with private insurance, including ACA Marketplace exchange patients, who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per co-pay. Co-pay assistance of up to 20% ($16,000) of the WAC price for Sovaldi™ can also be applied toward prescription deductibles and co-insurance obligations.

Gilead has made a contribution to the Patient Access Network (PAN) for co-pay assistance for Medicare Part D clients.

Gilead has initiated an emergency Sovaldi™ supply program for patients that may lose their prescriptions.

Gilead has agreed to ensure access to its PAP and co-pay assistance programs for AIDS Drug Assistance Program (ADAP) patients who are co-infected with HIV, even in states with ADAP programs that will not include Sovaldi™ on their formularies.

The FPC urges Gilead to widely disseminate the details of its SupportPath™ PAP and co-pay coupon program, which must include providing written SupportPath™ information for prescribers, prominently featured SupportPath™ information in its professional and direct-to-consumer advertisements, and clear links to www.mysupportpath.com via the Gilead and Sovaldi™ websites.

The Fair Pricing Coalition (FPC) today expressed disappointment at the price Janssen Therapeutics set for Olysio (simeprevir), a second generation protease inhibitor (PI) approved by the U.S. Food and Drug Administration on November 22, 2013 for the treatment of chronic hepatitis C (HCV) in genotype 1 patients. Janssen has set the wholesale acquisition cost, (WAC) for a single 12-week course of Olysio at $66,360. Though this is in parity with current HCV PIs, the FPC believes that all HCV drugs are priced too high. The WAC price of Olysio represents only part of the cost of an anti-HCV regimen, including at least $18,000 in WAC costs of interferon and ribavirin, plus the additional cost of the NS3 Q80K polymorphism screening test recommended by the FDA for all patients before initiating Olysio therapy.

“While we are very excited to have more effective and more tolerable treatment options for people living with hepatitis C, we are concerned about the overall cost of treatment,” said FPC HCV Co-Chair Lorren Sandt. “Janssen did price Olysio comparatively with other HCV PIs, but the bar previously had been set too high. We strongly urged Janssen to price Olysio lower than current regimens to help address the overall cost of therapy, which continues to spiral out of control.”

The FPC is gravely concerned about the continued precedent this pricing has on the future of HCV therapy. Industry experts have stated their expectations that Gilead Sciences’ new direct acting antiviral, sofosbuvir, will be approved by the FDA in the next few weeks. While the cost of sofosbuvir is not yet known, patients and doctors may look to combine these therapies (off label), resulting in an expected doubling of the current price of therapy.

“We know that this is just the initial price,” said Sandt. “Other HCV protease inhibitor manufacturers quickly increased prices after their initial 2011 launch. For example, a 12-week course of Vertex’s PI Incivek (telaprevir) had a WAC price of $49,000 at launch, but is now priced at $66,155. We caution Janssen not to continue this unacceptable trend. Treatment is just too costly for the majority of people living with chronic HCV,” concluded Sandt, “and we fear that barriers to patient access will be inevitable as a result.”

Anticipating the price of Olysio, the FPC urged Janssen to expand their access programs to ease the fiscal challenges that patients will face when trying to purchase Olysio. The FPC acknowledges that the Johnson & Johnson Patient Assistance Foundation agreed to expand the eligibility criteria for Olysio from 200% to 500% of the Federal Poverty Level (FPL). While this is a step in the right direction, it is not as generous as the program Vertex established for their PI, which is a maximum household income of $100,000 per year. The FPC also applauds Janssen’s intent to initiate a $25,000 per course of treatment co-pay program for Olysio. Unfortunately, the legal status of such programs for the Qualified Health Plans in the new Affordable Care Act Exchanges remains in question, possibly making Olysio access out of reach for many ACA patients.

“We thank Janssen for responding to our requests to increase the eligibility level of their PAP for Olysio and for developing a generous co-pay assistance program,” said Murray Penner, a member of the FPC. “We know that co-insurance costs will be very high for patients. Despite the access programs Janssen has in place, we are very concerned that the high price of Olysio, coupled with high co-insurance costs for patients, will result in limited access to Olysio.”

Four members of the Fair Pricing Coalition explain how to get help paying for your HIV medications. The bottom line? Apply for programs even if you don’t think you qualify, be persistant and don’t give up!

The Fair Pricing Coalition has written in protest of Gilead’s constant and excessive price increases for their HIV drugs and is asking others to sign onto our protest letter. The letter and signatories as of 3/19 are below. If you’d like to add your voice click here.

We are writing in response to your latest antiretroviral price increases. We are dismayed that Gilead has imposed a 7.9% price increase on Truvada and agreed to a 7.3 % increase on Complera and a 6.6% increase on Atripla in January of 2012. Because the Fair Pricing Coalition (FPC) has been unable to convince Gilead to take no more than one annual price increase in line with the Consumer Price Index (CPI), we have enlisted the assistance of the larger HIV community in this effort.

We have been urging Gilead to refrain from taking more than one annual price increase no greater than the CPI for many years. In October of 2009, the FPC wrote to our industry partners, including Gilead, about the crisis in access to HIV medication, resulting, in part, from repeated industry price increases taken continuously over a short period of time. Gilead has constantly been one of the worst offenders in this regard.

While we salute Gilead for its commitment to AIDS Drug Assistance Programs (ADAPs) as well as its co-pay and Patient Assistance Programs (PAPs), we are astounded at how Gilead diminishes the benefit of its philanthropy with these continuous price increases. It is essential that you understand the negative impact of your actions on people living with HIV/AIDS (PLWHAs). Since our original 2009 letter, Gilead has raised prices three times each for Viread and Truvada for a total of 22.1% and 24.5% respectively; twice for Emtriva for a total of 15.3%,and agreed to four price increases on for Atripla, totaling 21%, and agreed to a 7.3% price increase for Complera. These increases are dramatically higher than the rate of inflation. They also come at a time when many people with HIV have lost their jobs, their employer-based insurance coverage and, in many instances, their ADAP coverage, all resulting in desperate patients attempting to access HIV drugs on the open market, a market plagued with constantly increasing drug prices.

As U. S. economic stagnation persists, PLWHAs continue to lose jobs, income, health care benefits and ADAP coverage. At the same time, third party payers are imposing higher premiums as a direct result of escalating drug prices. Some patients have abruptly stopped treatment because they can no longer afford their medications. Although PAPs exist to help people who cannot afford medication, barriers to access are significant. Many people are unaware of the existence of PAPs. Others cannot cope with the labyrinth of multiple forms and requirements. Even with Gilead’s PAP eligibility at 500% of the Federal Poverty Level, a PLWHA earning $56,000.00 annually is not PAP eligible and will have to pay $20,000.00 or more to purchase Atripla at retail prices. This figure represents at least two-thirds of their net income.

The pharmaceutical industry’s extravagant price increases reverberate throughout the healthcare industry. They come at a time when many ADAPs are covering private insurance payments for their clients and result in ADAPs paying significantly increased premiums as a result of exorbitant price increases. This policy also results in higher premiums for people with HIV who are insured at a time when more and more people have less and less income due to unemployment, underemployment, reduced wages and reduced hours. Moreover, higher healthcare costs mean higher co-pays and pharmacy deductibles for people with private insurance and high share-of-cost plans which also result in increased costs to patients as well as decreased benefits. More restrictive access within insurance plans affects the cost of drugs, but also ancillary services, such as mental health, prevention healthcare, rehabilitation and substance abuse services.

Escalating costs for private and employee healthcare plans occasioned by continuous drug pricing increases will undoubtedly have a deleterious effect on the states as they design their health care exchanges in preparation for the 2014 implementation of the Affordable Care Act (ACA). Many states are likely to set a minimum standard for drug coverage for their “essential health benefits” package that requires only limited coverage of antiretrovirals and other higher cost drug classes. Additionally, with non-preferred generic antiretrovirals entering the marketplace we are concerned that higher drug prices will increasingly result in key coverage decisions being driven by cost rather than the standard of care for HIV treatment.

From our perspective, much of this crisis is occasioned by irresponsible pharmaceutical industry behavior. We firmly believe that Gilead’s price increases are particularly egregious because Gilead currently has the lion’s share of the antiretroviral market.We believe that the best way to begin to address these issues is for industry to change its price increase practices and agree to the following:

Gilead must agree to take no more than one CPI consistent price increase annually.

Gilead must use its sales force to disseminate information regarding its PAP and co-pay programs.

Gilead must contribute to foundations that provide co-pay program access to Medicare Part D clients.

Gilead must cooperate with the FPC and other stakeholders in designing and implementing a seamless, industry-wide standardized PAP criteria and enrollment process.

Now is the time for Gilead to reconsider its price increase policy and rescind its latest unreasonable price increases. We sincerely hope that Gilead will agree to the above and we look forward to your immediate response.

Yours truly,
The Fair Pricing Coalition and the Undersigned Organizations